(87 days)
Not Found
No
The document describes a quality control panel for a molecular diagnostic assay. There is no mention of AI or ML being used in the control panel itself or in the interpretation of the results from the control panel. The performance studies focus on the accuracy and reproducibility of the control panel in generating expected positive and negative results.
No
This device is a quality control panel used to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to treat or diagnose actual medical conditions in patients.
No
Explanation: This device is described as a "quality control panel" intended to monitor the performance of nucleic acid testing procedures, not to diagnose medical conditions in patients. It contains synthetic RNA transcripts for testing purposes, rather than being used directly on patient samples for diagnostic results.
No
The device description clearly states it is a "quality control panel consisting of 2 controls" which are physical solutions containing synthetic RNA transcripts. This is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures". This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnosis, prevention, or treatment of disease.
- Device Description: The description details the composition of the controls, which are used in conjunction with the FilmArray RP EZ assay, an in vitro diagnostic test.
- Performance Studies: The document describes performance studies conducted to evaluate the device's ability to function as a quality control for the in vitro diagnostic assay.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (DEN150058) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
The device is a quality control for an IVD, and quality controls used in conjunction with IVDs are themselves considered IVDs.
N/A
Intended Use / Indications for Use
FilmArray RP EZ Control Panel M265 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza Virus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae on the FilmArray RP EZ assay performed on the FilmArray systems. FilmArray RP Positive Control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the FilmArray RP EZ assay. This product is not intended to replace manufacturer controls provided with the device.
Product codes (comma separated list FDA assigned to the subject device)
PMN
Device Description
FilmArray RP EZ Control Panel M265, P/N M265, is a quality control panel consisting of 2 controls, FilmArray RP EZ Positive Control, P/N M266, and FilmArray RP EZ Negative Control. P/N M267. The Positive Contains non-infectious surrogate control material: a solution of synthetic RNA transcripts in buffers, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the FilmArray RP EZ assay (Table 1. below) on the FilmArray 2.0 EZ Configuration system. The RNA in the Negative Control is non-specific RNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray RP EZ Control Panel M265 is processed separately according to FilmArray RP EZ assay manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
CLIA-waived setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
All Test Results:
Three lots of FilmArray RP EZ Control Panel M265, FilmArray RP EZ Positive Control and FilmArray RP EZ Negative Control, were manufactured and tested using the FilmArray RP EZ assay on the FilmArray instrument 2.0 EZ Configuration system to confirm performance. The lots were manufactured incorporating variables including multiple key component lots, different operator and different days over four months.
An internal study was performed by testing the 3 lots at MMQCI (Saco, Maine) over multiple days with 4 reagent lots by one operator. An external study was performed to assess the ability of the intended user to test the FilmArray RP EZ Control Panel M265 in a CLIA-waived setting. The external performance study tested the 3 lots of FilmArray RP EZ Control Panel M265 at 2 CLIA-waived sites and 1 external site under simulated CLIA-waived conditions over a period of 10 days using 3 FilmArray reagent lots, incorporating multiple operators.
External Site Testing:
Three lots of FilmArray RP EZ Control Panel M265, FilmArray RP EZ Positive Control and FilmArray RP EZ Negative Control, were manufactured by MMQCI. They were tested by the FilmArray RP EZ assay on the FilmArray instrument 2.0 EZ Configuration system at two CLIA-waived clinical settings and one simulated CLIA-waived test setting where users were screened to have training and educational backgrounds consistent with those in the CLIA-waived testing environment.
Testing consisted of three positive and three negative controls run per day, and spanned a period of 10 days (total of 60 control runs per site). Multiple operators participated in testing at each of the three locations. Three lots each of external control material and three lots of RP EZ pouches were tested across all sites.
A total of 182 external controls were tested (91 positive and 91 negative). Two tests were excluded from final data analysis due to Invalid results caused by internal pouch control failures. Data for the remaining 180 control tests are shown below.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All Test Results:
Study Type: Performance Study
Sample Size: 271 total tests (129 Correct Positive Control Results, 137 Correct Negative Control Results, 3 Invalid results, 2 Incorrect Negative Control Results). The 3 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.
Key Results: All FilmArray RP EZ Positive Control respiratory pathogen analytes were correctly detected in the internal and external study (Correct Positive Control Result). All but 2 FilmArray RP EZ Negative Controls gave Correct Negative Control Results of no respiratory pathogens detected. There were 3 Invalid results caused by internal control pouch failures and 2 false positive results. It is not possible to determine the cause of the 2 false positive results.
External Site Testing:
Study Type: External Performance Study
Sample Size: A total of 182 external controls were tested (91 positive and 91 negative). Two tests were excluded from final data analysis due to Invalid results caused by internal pouch control failures. Data for the remaining 180 control tests were analyzed.
Key Results: For external site 1 and 2, 100% Correct Positive Control and 100% Correct Negative Control were observed. For external site 3, 100% Correct Positive Control and 93.3% Correct Negative Control (2 incorrect negative results) were observed. Across all sites, 100% Correct Positive Control and 97.8% Correct Negative Control were observed.
Reproducibility (Within-run Testing):
Study Type: Reproducibility Study
Sample Size: 6 tests for FilmArray RP EZ Positive Control, 5 tests for FilmArray RP EZ Negative Control.
Key Results: All results were correct and reproducible.
Reproducibility (Lot-to-Lot Testing):
Study Type: Reproducibility Study
Sample Size: 4 tests for Control Lot # M40DEC15A, 3 tests for Control Lot # A28DEC15A, 5 tests for Control Lot # A06JAN16A (1 invalid).
Key Results: All results were correct and reproducible.
Precision Testing:
Study Type: Precision Study
Sample Size: 12 tests for M40DEC15A (Positive Control), 13 tests for A28DEC15A (Positive Control), 15 tests for A06JAN16A (Positive Control, 1 invalid), 16 tests for A29OCT15B (Negative Control), 16 tests for M41DEC15A (Negative Control), 17 tests for A04JAN16A (Negative Control). Total 89 tests.
Key Results: All FilmArray RP EZ Positive Control respiratory pathogen analytes were correctly detected. One test was excluded from final data analysis due to Invalid results caused by an internal pouch control failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
All Test Results:
Percent Correct Positive Control: 100%
Percent Correct Negative Control: 98.6%
External Site Testing:
Percent Correct Positive Control: 100% (for all sites)
Percent Correct Negative Control: 100% (Site 1), 100% (Site 2), 93.3% (Site 3), 97.8% (All Sites)
Precision Testing:
Percent Correct: 100% for all tested lots of both Positive and Negative Controls.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3920 Assayed quality control material for clinical microbiology assays.
(a)
Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
September 2, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, ME 04072
Re: K161573
Trade/Device Name: FilmArray RP EZ Control Panel M265 Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II (Special Controls) Product Code: PMN Dated: June 6, 2016 Received: June 7, 2016
Dear Ms. Gordon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
Page 2 - Ms. Gordon
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Steven R. Gitterman -S
for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161573
Device Name FilmArray RP EZ Control Panel M265
Indications for Use (Describe)
FilmArray RP EZ Control Panel M265 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza Virus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae on the FilmArray RP EZ assay performed on the FilmArray systems. FilmArray RP Positive Control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the FilmArray RP EZ assay. This product is not intended to replace manufacturer controls provided with the device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of maroon and yellow. The "MM" and "CI" are in maroon, while the "Q" is in yellow. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller font size. A yellow brushstroke-like design is on the left side of the logo.
23 Mill Brook Road Mill Brook Business Park Saco, Maine 04072 www.mmaci.com Phone: 207-885-1072 Fax: 207-885-1079
510 (k) Summary
510(k) Number: K161573
Purpose for submission: New product
Applicant Information:
| Applicant: | Maine Molecular Quality Controls, Inc. |
|---|---|
| Address: | 23 Mill Brook Road |
| Saco, Maine 04072 |
| Contact Person: | Joan Gordon, President MMQCI | |
|---|---|---|
| Phone: | 207-885-1072 extension 201 | |
| Fax: | 207-885-1079 | |
| Email Address: | jgordon@mmqci.com |
Preparation Date: May 31, 2016
Device
| Device Trade Name: | FilmArray RP EZ Control Panel M265, model M265 |
|---|---|
| Device Common Name: | Quality Control Material for Microbiology Assays |
| Device Type: | Assayed quality control material for clinical microbiology assays |
| Class: | Class II (Special controls) |
| Regulation: | 21 CFR 866.3920 |
| Panel: | Microbiology - 83 |
| Product code: | PMN |
Predicate Device
DEN150058; Amplichek II, Bio-Rad Laboratories
Device Description
FilmArray RP EZ Control Panel M265, P/N M265, is a quality control panel consisting of 2 controls, FilmArray RP EZ Positive Control, P/N M266, and FilmArray RP EZ Negative Control. P/N M267. The Positive Contains non-infectious surrogate control material: a solution of synthetic RNA transcripts in buffers, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the FilmArray RP EZ assay (Table 1. below) on the FilmArray 2.0 EZ Configuration system. The RNA in the Negative Control is non-specific RNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray RP EZ Control Panel M265 is processed separately according to FilmArray RP EZ assay manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs
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Image /page/4/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the acronym "MMQCI" in bold, dark red letters. Below the acronym, the full name of the company, "Maine Molecular Quality Controls, Inc.," is written in a smaller, lighter font. A stylized, abstract graphic in shades of yellow and gold is positioned to the left of the text, adding a visual element to the logo.
(NPS) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).
| Respiratory Pathogens | |
|---|---|
| Adenovirus | Influenza A H1-2009 |
| Coronavirus | Influenza B |
| Human Metapneumovirus | Parainfluenza Virus |
| Human Rhinovirus/ Enterovirus | Respiratory Syncytial Virus |
| Influenza A | Bordetella pertussis |
| Influenza A subtype H1 | Chlamydophila pneumoniae |
| Influenza A subtype H3 | Mycoplasma pneumoniae |
Table 1. Respiratory pathogens detected by FilmArray RP EZ assay
Device Intended Use
FilmArray RP EZ Control Panel M265 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B, Parainfluenza Virus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae on the FilmArray RP EZ assay performed on the FilmArray systems. FilmArray RP Positive Control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the FilmArray RP EZ assay. This product is not intended to replace manufacturer controls provided with the device.
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Image /page/5/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a serif font, with "MM" in a larger size and a darker color than "QCI". Below the letters, the full name of the company is written in a smaller font. To the left of the letters, there is an abstract design in yellow, resembling a brush stroke or a stylized wave.
| Characteristic | Candidate Device:
FilmArray RP EZ
Control Panel M265
(K161573) | Predicate Device
Amplichek II
(DEN150058) |
|---------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Intended Use | External assayed quality
control to monitor in vitro
lab nucleic acid test | Same |
| Physical format | Ready-to-Use Liquid | Same |
| Directions for Use | Process like patient sample | Same |
| Composition | Synthetic RNA transcripts | Intact microorganisms |
| Assay Steps Monitored | Extraction, reverse
transcription,
amplification, detection,
identification | Same except does not
monitor extraction
(new device not
encapsulated) |
| Number of targets
monitored in one assay | Multiple | Same |
Substantial Equivalence
Summary Performance Data
All Test Results
Three lots of FilmArray RP EZ Control Panel M265, FilmArray RP EZ Positive Control and FilmArray RP EZ Negative Control, were manufactured and tested using the FilmArray RP EZ assay on the FilmArray instrument 2.0 EZ Configuration system to confirm performance. The lots were manufactured incorporating variables including multiple key component lots, different operator and different days over four months.
An internal study was performed by testing the 3 lots at MMQCI (Saco, Maine) over multiple days with 4 reagent lots by one operator. An external study was performed to assess the ability of the intended user to test the FilmArray RP EZ Control Panel M265 in a CLIA-waived setting. The external performance study tested the 3 lots of FilmArray RP EZ Control Panel M265 at 2 CLIA-waived sites and 1 external site under simulated CLIA-waived conditions over a period of 10 days using 3 FilmArray reagent lots, incorporating multiple operators.
All FilmArray RP EZ Positive Control respiratory pathogen analytes were correctly detected in the internal and external study (Correct Positive Control Result). All but 2 FilmArray RP EZ Negative Controls gave Correct Negative Control Results of no respiratory pathogens detected. There were 3 Invalid results caused by internal control pouch failures and 2 false positive results. It is not possible to determine the cause of the 2 false positive results. However, since the results were from 2 different control lots and 2 different pouch lots at the same testing site, environmental contamination is possible, especially since testing occurred during flu season.
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Image /page/6/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of maroon and yellow colors. The word "MAINE MOLECULAR QUALITY CONTROLS, INC." is written in a smaller font size below the letters. A yellow, curved design element is placed behind the letters, adding a visual flair to the logo.
| Table 1. Summary of All Test Results | ||||||||
|---|---|---|---|---|---|---|---|---|
| Number | ||||||||
| of sites | Total | |||||||
| Tests | Invalid | Correct | ||||||
| Positive | ||||||||
| Control | ||||||||
| Result | Incorrect | |||||||
| Positive | ||||||||
| Control | ||||||||
| Result | Percent | |||||||
| Correct* | ||||||||
| Positive | ||||||||
| Control | Correct | |||||||
| Negative | ||||||||
| Control | ||||||||
| Result | Incorrect | |||||||
| Negative | ||||||||
| control | ||||||||
| Result | Percent | |||||||
| Correct* | ||||||||
| Negative | ||||||||
| Control | ||||||||
| 4 | 271 | 3 | 129 | 0 | 100% | 137 | 2 | 98.6% |
*The 3 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.
External Site Testing
Three lots of FilmArray RP EZ Control Panel M265, FilmArray RP EZ Positive Control and FilmArray RP EZ Negative Control, were manufactured by MMQCI. They were tested by the FilmArray RP EZ assay on the FilmArray instrument 2.0 EZ Configuration system at two CLIAwaived clinical settings and one simulated CLIA-waived test setting where users were screened to have training and educational backgrounds consistent with those in the CLIA-waived testing environment.
Testing consisted of three positive and three negative controls run per day, and spanned a period of 10 days (total of 60 control runs per site). Multiple operators participated in testing at each of the three locations. Three lots each of external control material and three lots of RP EZ pouches were tested across all sites.
A total of 182 external controls were tested (91 positive and 91 negative). Two tests were excluded from final data analysis due to Invalid results caused by internal pouch control failures. Data for the remaining 180 control tests are shown below.
| Table 2. Summary of External Test Results for 3 Control Lots | ||||||||
|---|---|---|---|---|---|---|---|---|
| External | ||||||||
| Site | Total | |||||||
| Tests | Invalid | Correct | ||||||
| Positive | ||||||||
| Control | ||||||||
| Result | Incorrect | |||||||
| Positive | ||||||||
| Control | ||||||||
| Result | Percent | |||||||
| Correct* | ||||||||
| Positive | ||||||||
| Control | Correct | |||||||
| Negative | ||||||||
| Control | ||||||||
| Result | Incorrect | |||||||
| Negative | ||||||||
| control | ||||||||
| Result | Percent | |||||||
| Correct* | ||||||||
| Negative | ||||||||
| Control | ||||||||
| 1 | 61 | 1 | 30 | 0 | 100% | 30 | 0 | 100% |
| 2 | 61 | 1 | 30 | 0 | 100% | 30 | 0 | 100% |
| 3 | 60 | 0 | 30 | 0 | 100% | 28 | 2 | 93.3% |
| All Sites | 182 | 2 | 90 | 0 | 100% | 88 | 2 | 97.8% |
*The 2 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.
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Image /page/7/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a serif font, with the "MM" in a larger size than the "QCI". The words "MAINE MOLECULAR QUALITY CONTROLS, INC." are written in a smaller font below the letters. A yellow brush stroke design is on the left side of the logo.
Reproducibilitv
NOTE: The FilmArray 2.0 is a random access instrument. Therefore, 'runs' refer to replicates tested on the same day.
Within-run Testing: Within-run reproducibility was demonstrated by 1 operator testing 2 lots of FilmArray RP EZ Control Panel M265 with 1 lot of FilmArray RP EZ pouches on the FilmArray 2.0, each within one day. All results were correct and reproducible.
| Table 3. Summary of Within-run Reproducibility Results | |||||
|---|---|---|---|---|---|
| Control | Control Lot# | No. of Tests | Date of Testing | Pouch Lot | Correct Results |
| FilmArray RP EZ Positive Control | A06JAN16A | 6 | 1-7-16 | 239115 | 6/6 |
| FilmArray RP EZ Negative Control | M41DEC15A | 5 | 12-31-15 | 239115 | 5/5 |
Lot-to-Lot Testing: Lot-to-lot reproducibility was demonstrated by testing 3 lots of FilmArray RP EZ Positive Control using the same pouch lot. All results were correct and reproducible.
| Control Lot # | Number of Tests | Pouch Lot | Correct Results |
|---|---|---|---|
| M40DEC15A | 4 | 238915 | 4/4 |
| A28DEC15A | 3 | 238915 | 3/3 |
| A06JAN16A | 5 (1 Invalid) | 238915 | 4/4 |
Precision Testing: Precision was demonstrated by testing 3 lots of FilmArray RP EZ Positive Control and 3 lots of FilmArray RP EZ Negative Control at MMQCI over multiple days with 4 reagent lots by one operator using one FilmArray 2.0 instrument. All FilmArray RP EZ Positive Control respiratory pathogen analytes were correctly detected. One test was excluded from final data analysis due to Invalid results caused by an internal pouch control failure.
| Table 5. Summary of Precision Testing for 3 Control Lots at MMQCI | ||||||
|---|---|---|---|---|---|---|
| Control | Control Lot # | No. of | ||||
| Tests | Invalid | Correct | ||||
| Results | Incorrect | |||||
| Results | Percent | |||||
| Correct* | ||||||
| FilmArray RP EZ Positive Control | M40DEC15A | 12 | 0 | 12 | 0 | 100% |
| FilmArray RP EZ Positive Control | A28DEC15A | 13 | 0 | 13 | 0 | 100% |
| FilmArray RP EZ Positive Control | A06JAN16A | 15 | 1 | 14 | 0 | 100% |
| FilmArray RP EZ Negative Control | A29OCT15B | 16 | 0 | 16 | 0 | 100% |
| FilmArray RP EZ Negative Control | M41DEC15A | 16 | 0 | 16 | 0 | 100% |
| FilmArray RP EZ Negative Control | A04JAN16A | 17 | 0 | 17 | 0 | 100% |
| TOTAL | 89 | 0 | 88 | 0 | 100% |
*The Invalid sample was re-tested according to BioFire instructions and was not included in the Percent Correct analysis.